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Clinical Trials/EUCTR2004-004086-15-DE
EUCTR2004-004086-15-DE
Active, not recruiting
Phase 1

Comparison of nephrotoxic effects of the contrast dyes iodixanol (iso-osmolar, non-ionic, dimer) and ioversol (low-osmolar, non-ionic, monomer) in patients with impaired renal function and severe heart failure

niversity Hospital of Frankfurt, Department of Cardiology0 sites140 target enrollmentMay 17, 2005
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity Hospital of Frankfurt, Department of Cardiology
Enrollment
140
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 17, 2005
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity Hospital of Frankfurt, Department of Cardiology

Eligibility Criteria

Inclusion Criteria

  • •\- Patients must be older than 18 y.o.
  • •\- Written consent to the study
  • •\- Coronary angiography is required for medical reasons
  • •\- Calculated glomerular filtration rate \= 60 ml/min (calculation is based on the shortened MDRD\-formula)
  • •\- Severe heart failure, diagnosed either by an ejection fraction \= 45 % (echocardiography) or a clinical condition NYHA III or IV
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •\- Severe comorbidity (i.e. neoplasia, life expectaning \= 2 yrs.)
  • •\- Intravacular administration of iodinated contrast dye within last 14 days
  • •\- Intake of nephrotoxic drugs within the last 7 days
  • •\- Intake of metformine within the last 24 hours
  • •\- Patients with prior renal transplantation
  • •\- End\-stage renal disease or acute renal failure and/or necessity of dialysis after coronary angiography
  • •\- Pregnancy or lactation
  • •\- Impaired liver function following the Child\-Pugh criteria according a severity level of Child B or C

Outcomes

Primary Outcomes

Not specified

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